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Bridging Gaps in Clinical Trials: Strategies for Increasing Access and Representation

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Despite high levels of spending on health care in the United States—almost double that of peer high-income countries—health outcomes continue to lag across a wide range of disease conditions. The differences in the incidence, prevalence, treatment course, and outcomes for various diseases across populations are stark. These disparities are caused by myriad factors, such as social needs, geography, insurance coverage, and income, as well as variations in underlying biology that affect the risk, onset, and severity of both chronic and acute diseases. They are exacerbated by a lack of access to basic health care and to innovative treatments through clinical trials for many populations disproportionately impacted by the burden of disease. 

In recent years, the lack of both access to clinical trials and the infrastructure to recruit populations across the US into clinical trials has become a major focus for researchers and clinical trial sponsors. This increased attention reflects a growing understanding that participation across populations strengthens the biomedical innovation ecosystem by improving the generalizability of research findings, boosting confidence in treatment safety and effectiveness, and building trust in the research enterprise. 

Given the medical and scientific imperative for representative clinical trials, FasterCures sought to identify actions by clinical trial sponsors, sites, and others in the research ecosystem to increase enrollment of representative populations in clinical research. We also interviewed community-serving and patient advocacy organizations about their perceptions of the effectiveness of these actions. 

Through this report, FasterCures aims to highlight current practices and insights from organizations actively engaged in a range of efforts to build collective knowledge and to serve as a resource for stakeholders working to expand access and representation in clinical trials across disease areas, geographies, and populations, all within the constraints of an evolving research environment.

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